Med Device Dev Eng Electrical
Kirkland - Quebec (QC),
Jubilant DraxImage inc.
Jubilant DraxImage, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for a Medical Device Development Engineer, Mechanic position to join our growing team!
What can we offer?
A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.
Jubilant DraxImage Inc. is a rapidly growing company with offices in Kirkland, QC and Yardley, PA. A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team. Jubilant DraxImage is a proud member of the Jubilant Pharma family. For more information, visit www.draximage.com
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.
If you're up for a rewarding challenge, we invite you to take the first step and apply today!
Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive and where our differences are welcomed. By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.
- Participates as a key team member of the Medical Device development team and leads design activities for the electrical, electronic & electromechanical design of Medical Devices.
- Develop Requirements Specifications to a technical level.
- Write and execute protocols for design verification and validation
- Lead test method development to all required standards
- Oversee and perform testing and inspection of prototypes and pre-production products
- Lead investigation of device failures to determine root cause and corrective action
- Prepare detailed product specifications
- Prepare documentation to support design history files and regulatory submissions
- Design tooling and test fixtures to support product testing and clinical evaluation.
- Consult with product manager and clinicians when necessary, to facilitate proper design of new or modified products.
- Lead/Participate in design reviews
- Experience with verification and process validation including statistical rationale and all regulations pertaining to electrical medical device requirements.
- Support the development of intellectual property
- Lead product and process risk assessments
- Performs additional duties as assigned by Management.
- Bachelor degree in Electrical Engineering & Electronic/Mechatronics Engineering
- Member of the OIQ
- 5 Years Medical Device Experience.
- Experience designing software driven complex medical devices for the EU and US markets.
- Experienced in designing medical devices to comply with IEC 60601-1 & 60601-1-2
- Prior knowledge and experience of the following standards:ISO 13485 Quality System management experience21 CFR - Parts 820 Quality System RegulationISO 14971 Risk management
- Proficiency in English Language